RecruitingNot ApplicableNCT07377162

HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics

HYPERMIND - Hyperoxia Effects on Cerebral Hemodynamics


Sponsor

Erasme University Hospital

Enrollment

80 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to better understand how short periods of exposure to high oxygen levels affect blood flow in the brain of patients who are intubated and mechanically ventilated in the Intensive Care Unit (ICU). Many ICU patients receive more oxygen than strictly necessary, and high blood oxygen levels (hyperoxemia) are very common. However, the immediate effects of short hyperoxic exposures on cerebral circulation and autoregulation remain poorly understood. In this study, patients who already require mechanical ventilation for medical reasons will undergo a brief and controlled increase in the oxygen delivered through the ventilator (FiO₂). During this time, we will continuously monitor blood flow in one of the main brain arteries using a non-invasive ultrasound technique called transcranial Doppler (TCD). The goal is to evaluate how cerebral blood flow, pulsatility, and autoregulatory capacity change during and after a short hyperoxic stimulus. No additional invasive procedures are required beyond standard ICU monitoring, except for the temporary adjustment of the ventilator's oxygen settings and arterial blood gas sampling, which are part of usual care in critically ill patients. Participation does not provide direct clinical benefit but may help improve future oxygen management in ICU patients. The study involves minimal risk, as short hyperoxic exposures are already common in routine care and will be interrupted immediately in case of any adverse event.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • Adult patients aged ≥18 years
  • Admitted to the intensive care unit (ICU)
  • Intubated and mechanically ventilated for ≤72 hours
  • Receiving volume-controlled mechanical ventilation
  • Arterial partial pressure of carbon dioxide (PaCO₂) between 35 and 45 mmHg
  • Invasive arterial blood pressure monitoring in place
  • Adequate transcranial Doppler (TCD) acoustic window
  • Clinically judged to be suitable for a brief normobaric hyperoxic stimulus
  • Expected to receive one or two hyperoxic steps based on baseline FiO₂ requirements: a) Baseline FiO₂ < 0.5: two-step hyperoxic stimulus (FiO₂ 0.5 followed by FiO₂ 1.0); b) Baseline FiO₂ ≥ 0.5: one-step hyperoxic stimulus (FiO₂ 1.0)

Exclusion Criteria8

  • Age <18 years
  • Pregnancy
  • Extracorporeal membrane oxygenation (ECMO)
  • Continuous renal replacement therapy (CRRT)
  • Contraindications to hyperoxia, as judged by the treating physician
  • Severe hemodynamic instability requiring changes in vasopressor dose during the recording period
  • Inability to obtain a reliable transcranial Doppler signal through the temporal acoustic windows
  • Any clinical condition deemed by the treating physician to pose unacceptable risk during hyperoxic exposure

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Interventions

OTHERNormobaric Hyperoxic Stimulus (NBHO)

The intervention consists of a short, controlled increase in the inspired oxygen fraction (FiO₂) delivered by the mechanical ventilator. Depending on baseline FiO₂, patients will receive: Depending on baseline FiO₂, patients will receive: Two-step NBHO (baseline FiO₂ \< 0.5): FiO₂ raised to 0.5 and then to 1.0 One-step NBHO (baseline FiO₂ ≥ 0.5): FiO₂ raised to 1.0 Each step includes 5 minutes to reach steady state followed by a 10-minute recording period. Cerebral blood flow velocity and autoregulation are continuously assessed using transcranial Doppler ultrasound.


Locations(1)

Erasme Hospital - ULB

Brussels, Belgium

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NCT07377162


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